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SKATER™ Mini-Loop Drainage Set 758608025Recalls & reported problems

Argon Medical Devices, Inc. · SKATER™ Mini-Loop Drainage Set Locking 8F x 25cm · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333225408), received between Aug 21, 2023 and Aug 21, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 21, 2023Break; Break

    DURING CATHETER EXCHANGE, AFTER POSITIONING THE NEW CATHETER, THE LOCK ON THE PIGTAIL FIXATION WIRE BROKE. MAKING IT IMPOSSIBLE TO USE. IT IS NOT THE FIRST OCCURRENCE OF A CATHETER QUALITY DEVIATION, AND PREVIOUS ONES WERE NOT FORMALLY NOTIFIED. ATTACHED IS THE IMAGE OF THE IDENTIFIED PROBLEM. AS A RESULT, IT LED TO AN INCREASE IN THE PROCEDURE TIME IN THE PATIENT UNDERGOING RADIO INTERVENTION, REWORK OF PROFESSIONALS, AND WASTE OF MATERIAL. CUSTOMER INTERNAL NOTIFICATION NO.: 2023.07.074.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17586493 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.